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| Name | Class |
|---|---|
| Prostate Cancer Canada | OTHER |
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This study will examine the impact of modern treatments for metastatic Castrate Resistant Prostate Cancer (mCRPC) on several relevant 'geriatric' domains such as daily function, objective physical function, and falls. Additionally, the investigators study whether frailty is associated with worse outcomes, and whether it is possible to predict the risk of severe chemotherapy toxicity in older men.
Our primary aims are (a) to examine the impact of pre-treatment frailty on 'elder-relevant' outcomes including daily function, objective physical function, falls, quality of life (QOL), and early treatment discontinuation; (b) to determine whether the Hurria/Cancer and Aging Research Group (CARG) tool is able to predict severe (grade 3+) chemotherapy toxicity in men starting chemotherapy. Our secondary aim is to understand the impact of abiraterone and enzalutamide on 'elder-relevant' outcomes.
This is a prospective multicentre observational study. The investigators will enroll men age 65 or older with mCRPC who are starting (a) first-line chemotherapy; (b) abiraterone; or (c) enzalutamide. Assessments will occur prior to starting treatment and every 2 months thereafter until the end of treatment.
As treatment options become more complex in older men with mCRPC, understanding and predicting a wide range of treatment toxicities is important and will aid decision-making and management.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chemotherapy | Men starting first-line chemotherapy for mCRPC (typically Docetaxel and Prednisone) | ||
| Abiraterone | Men with mCRPC starting Abiraterone | ||
| Enzalutamide | Men with mCRPC starting Enzalutamide |
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| Measure | Description | Time Frame |
|---|---|---|
| Daily function assessed by questionnaires | Daily function | Participants will be followed for the duration of treatment up to 2 years |
| Objective physical function | Will be assessed by 3 physical performance measures | Participants will be followed for the duration of treatment up to 2 years |
| Grade 3+ toxicity using Common Terminology Criteria for Adverse Events (CTC-AE) version 4.0 | Toxicity | Participants will be followed for the duration of treatment up to 2 years |
| Number of falls provided by the participant | Falls | Participants will be followed for the duration of treatment up to 2 years |
| Body fat percentage will be measured using a Tanita 300A analyzer | Body composition analysis | Participants will be followed for the duration of treatment up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life (QOL) | FACT-G and FACT-P (specific for prostate cancer) questionnaires will be administered | Participants will be followed for the duration of treatment up to 2 years |
| The Montreal Cognitive Assessment (MoCA test) and Trail making tests A&B |
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Inclusion Criteria:
Exclusion Criteria:
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Men 65 and older starting first line chemotherapy, or Abiraterone, or Enzalutamide for mCRPC
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Juravinski Cancer Centre | Hamilton | Ontario | L8V 5C2 | Canada | ||
| Kingston Health Sciences Centre -KGH |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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Cognition composite |
| Participants will be followed for the duration of treatment up to 2 years |
| Kingston |
| Ontario |
| K7L 2V7 |
| Canada |
| Odette Cancer Centre | Toronto | Ontario | M4N 3M5 | Canada |
| Princess Margaret Cancer Centre | Toronto | Ontario | M5G 2M9 | Canada |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |